Senior Officer

Perform routine QA oversight during API manufacturing operations. Conduct line clearance before batch initiation and product changeovers. Ensure adherence to cGMP, GDP, SOPs, BMR/BPR, and regulatory guidelines. Verify completion of manufacturing and cleaning activities as per approved procedures. Monitor critical process parameters and report deviations. Review Batch Manufacturing Records (BMR), Batch Packaging Records (where applicable), logbooks, and supporting documents. Ensure Good Documentation Practices (GDP) compliance across production areas. Issue, control, reconcile, and archive GMP documents. Participate in periodic SOP review and revision. Initiate and investigate deviations, incidents, and non-conformances. Perform root cause analysis using quality tools. Recommend, implement, and monitor Corrective and Preventive Actions (CAPA). Track effectiveness of CAPA implementation